Z-0844-03

AEROSET Analyzer

Name: Z-0844-03 AEROSET Analyzer
Creator: Abbott Laboratories, Inc
Published: 2002-08-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-08-15 / Terminated / root cause: design

FDA source

Abbott Laboratories, Inc began a recall of AEROSET Analyzer on 2002-08-15. The reason FDA records is "Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0844-03
Status: Terminated
Initiated: 2002-08-15
Posted: 2003-05-20
Terminated: 2004-04-07
Recalling firm: Abbott Medical
Product: AEROSET Analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
Root cause tag: design
FDA root cause: Other
Action: The firm sent Technical Service Bulletins dated August 15, 2002 to consignees. Field Representatives are correcting the device in the field. A customer letter was released on August 20, 2002 to provide customers actions to take to prevent the occurrance.
Quantity in commerce: 578
Distribution: Nationwide and to the following foreign countries: Mexico, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, New Zealand, and China
Product codes and lots: All AEROSET devices distributed prior to 08/15/2002.

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)